• To demonstrate the clinical equivalence of efficacy between OROS hydromorphone HCI and Morphine SR in patients with cancer pain at baseline, visit 3, 5 and final visit.
  

• Other assessments of pain from the BPI;Global assessments of effectiveness by the patient and Investigator;Use of breakthrough pain medication;Percentage of patients discontinued the study will be assessed at baseline, visit 3, 5 and final visit.
  

This is a phase III, randomized, open-labeled, active-controlled, multi-center study in 110 adult patients with cancer pain, requiring strong oral opioid analgesics. This study period is divided into 3 phases: screening period (14 days prior to randomization/dosing), dose titration phase (3 to 14 days), and dose maintenance phase (14 days). Patients will be evaluated at 4 scheduled clinic visits and contacted by telephone daily between visit. The screening will last up to two weeks. Patients with cancer pain who meet entrance criteria for the study will be identified. The study will be explained and informed consent will be obtained. Patients who have met the criteria at screening will start approximately 17-28 days treatment of either OROS hydromorphone or Morphine SR (sustain release). During the treatment, dose adjustments are permitted in steps at titration. Dose level may be titrated upwards or downwards every 48 hours in the titration phase. The dose should be titrated by the Investigator according to the patient's analgesic requirement. A patient is considered stabilized when, for a minimum of 2 consecutive days, the requirements of rescue medication are maintained at 3 doses per day or less. If necessary, dose titration is also permitted during maintenance phase using the same criteria used in the titration phase. Patients should be titrated to adequate effect no more frequently than every 2 days in maintenance phase. Morphine hydrochloride will be used as rescue medication for breakthrough pain. No other opioid is permitted during treatment period. Adjuvant medications such as paracetamol, non-steroidal anti-inflammatory drugs, anxiolytics, antidepressants, antiarrhythmic drugs, hormone therapy, corticosteroids, anticonvulsants, and neuroleptics are allowed but must be maintained at stable doses for the duration of the trial. Analgesic efficacy is assessed using the short form of the Brief Pain Inventory (BPI). Equivalence of efficacy will be assessed using the "worst pain" item of the BPI (BPI Question 3) as the primary efficacy assessment. BPI Q3 & Q6 (Question 3 & 6), study medication usage, and requirements of rescue medication will be recorded daily by patients for both treatment groups. Other pain assessments in the BPI will be performed by patients and the Investigator at 4 visits (baseline/randomization, Visit 3 and 5, and FINAL visit). And Global assessments will be performed by patients and the Investigator at 3 visits (Visit 3 and 5, and FINAL visit). Safety will also be assessed through physical examinations and vital signs, clinical laboratory evaluation, and monitoring for adverse events.

Patients who have met the criteria at screening will start approximately 17-28 days treatment of either OROS hydromorphone or oral Morphine SR. During the treatment, dose adjustments are permitted in steps at titration. The dose should be titrated by the Investigator according to the patient's analgesic requirement. For patients not routinely receiving opioids, the initial dose should not exceed 8 mg OROS hydromorphone every 24 hours (in the morning) or 30 mg Morphine SR twice daily.